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FDA 510(k)

Monaghan medical filtered mouthpiece kit

K-Number: K220145 · 2023-08-24

Decision Date2023-08-24
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Monaghan medical filtered mouthpiece kit is a medical device manufactured by Monaghan Medical Corporation. It received FDA 510(k) clearance on 2023-08-24 under approval number K220145. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monaghan medical filtered mouthpiece kit?

Monaghan medical filtered mouthpiece kit is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Monaghan Medical Corporation. The 510(k) number is K220145.

When was Monaghan medical filtered mouthpiece kit approved by the FDA?

Monaghan medical filtered mouthpiece kit received FDA 510(k) clearance on 2023-08-24, under approval number K220145.

What company makes Monaghan medical filtered mouthpiece kit?

Monaghan medical filtered mouthpiece kit is manufactured by Monaghan Medical Corporation.

What is the FDA product code for Monaghan medical filtered mouthpiece kit?

The FDA product code for Monaghan medical filtered mouthpiece kit is CAF.

Related Clinical Trials

Related Devices (Code: CAF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.